FDA approves PrecivityAD2 blood test for adults with cognitive decline

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The U.S. Food and Drug Administration cleared C2N Diagnostics’ PrecivityAD2 blood test for use in adults as young as 40 who are experiencing signs of cognitive impairment.

The Alzheimer’s Drug Discovery Foundation says it began funding C2N in 2008 and that its support, including a $7 million investment through the ADDF’s Diagnostics Accelerator, helped advance blood-based biomarkers that underpin the test, according to the organization.

The foundation framed the clearance as part of a wider shift toward blood diagnostics that can enable earlier detection, improve patient selection for clinical trials and support precision medicine approaches.

The ADDF noted the decision follows other recent FDA clearances for blood tests and positioned PrecivityAD2 within its portfolio of diagnostics-focused initiatives intended to close the gap between early pathology and clinical detection.

Source: https://www.prnewswire.com/news-releases/fda-clearance-of-c2n-diagnostics-precivityad2-blood-test-advances-precision-medicine-for-alzheimers-building-on-groundwork-laid-by-early-addf-investment-302856858.html

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